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Total of label /

Braille placement only - CCL work area

BRAILLE EXPLANATIONS AND TRANSLATIONS

13 mm

65 mm

calcichew d#3 #500 mg /# 400 iu caplets

12 mm |    40 mm

Tab |

Calcichew-D₃

.. .500 mg/400 |U Caplets *

• • •

• •

• •

• •

•    •calciUm/cOlecalciffefbl* •

•    (Vitawth j —

100 film-coated tablets

For oral use: 1 tablet contains:

500 mg calcium (as calcium carbonate) 400 IU vitamin D₃ (10 microgram cholecalciferol) Sdrbttol (E420) end sucrose.

Read the package leaflet before use. The tablet may be swallowed or chewed.

Keep bdWbf th» sight    p

andlreacl* bflcthildteh.

Do nbt store above 25°C. Keep the container tightly closed in order to protect from moisture.

Takeda UK Ltd.

Wooburn Green, BUCKS,

HP10 0DF, UK

PL 16189/0027

GBR F.7/xxxx/ 6083720 Code xxx

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For proofreading of Braille

Leaflet outside (Prima)

Latvia:    Calcigran Forte Flex 500 mg / 400 IU

apvalkotas tabletes Lithuania:    Calcigran Forte Flex

This leaflet was revised in October 2015.

Luxembourg:

Netherlands:

Norway:

Poland:

Sweden:

UK:

65 mm Page 16

65 mm Page 17

65 mm Page 18

55 mm    i 10 mm

Page 19    | Glue

65 mm

Front page outside

12 mm Tab

13 mm

65 mm

12 mm |    40 mm

Tab |

Steovit D₃ 500 mg/400 U.I., comprimes pellicules

Calci-Chew D₃ FLEX 500 mg/400 I.E. Calcigran Forte 500 mg/400 IE tabletter, filmdrasjerte Orocal D₃ Tab

Calci-D₃ Citron 500 mg/400 IE filmdragerad tablett Calcichew-D₃ 500 mg/400IU Caplets

Additional Information

Calcichew-D₃ Caplets are a combination of calcium and vitamin D designed to keep bones healthy.

Calcium is an essential component of bones while vitamin D plays an important role in the absorption of calcium from food.

Requirements for calcium increase with age and, although many people obtain enough calcium from their diet, some people may require a supplement in order that their body has all the calcium it needs to maintain healthy bones. Vitamin D is produced largely from the action of sunlight. Certain foodstuffs do contain vitamin D in reasonable amounts but it is not always possible to obtain all the vitamin D you need from your diet. People who do not get out and about, for instance those who are housebound or people living in nursing and residential homes, may not receive all the vitamin D they need.

People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium and vitamin D intake can lead to the development of osteoporosis, a condition where bones become weak to a level that minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist. Calcichew-D₃ Caplets have been designed to give people whose intakes of calcium and vitamin D are low a boost to the recommended amounts.

Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and vitamin D and, for some people, advice on how to prevent falls which may lead to fracture.

For patients in the UK, the National Osteoporosis Society (NOS) is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The NOS offers support to people with osteoporosis and raises awareness of the importance of healthy bones.

If you are concerned about osteoporosis, please contact the National Osteoporosis Society, Camerton, Bath BA2 0PJ.

Tel: 01761 471 771, Fax: 01761 471 104 or email: infoQnos.org.uk.

'Registered Trademark

GBR F.7/xxxx/6083720 Code xxx

Calcichew-D₃ 500 mg/400 IU Caplets

calcium/colecalciferol (vitamin D₃)

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100 film-coated tablets

Leaflet inside (Sekunda)

Base label (Selfadhesive)

Package leaflet: Information for the user Calcichew-D₃ 500mg/400IU Caplets calcium/colecalciferol (vitamin D₃)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

You must contact a doctor if your symptoms worsen or do not improve after two weeks.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet:

1.    What Calcichew-D₃ Caplets are and what they are used for

2.    What you need to know before you take Calcichew-D₃ Caplets

3.    How to take Calcichew-D₃ Caplets

4.    Possible side effects

5.    How to store Calcichew-D₃ Caplets

6.    Contents of the pack and other information

1.    What Calcichew-D₃ Caplets are and what they are used for

Calcichew-D₃ Caplets are film-coated tablets containing calcium and vitamin D₃, which both are important substances in bone formation. Calcichew-D3 Caplets is used in the prevention and treatment of calcium and vitamin D deficiency in the elderly, and as a supplement to specific treatment of osteoporosis.

2.    What you need to know before you take Calcichew-D₃ Caplets

Do not take Calcichew-D3 Caplets:

-    if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6)

-    if you have severe kidney problems

-    if you have excessive amounts of calcium in the

blood or in the urine

-    if you have kidney stones

-    if you have excessive amounts of vitamin D in the blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Calcichew-D3 Caplets

-    if you are on long-term treatment, especially if you also take diuretics (used in treatment of high blood pressure or oedema) or cardiac glycosides (used to treat heart disorders)

-    if you have signs of impaired renal function or high tendency of renal stone formation

-    if you have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D in the body)

-    if you have osteoporosis and at the same time are

unable to move around

- if you take other products containing vitamin D. Additional doses of calcium and vitamin D should be taken under close medical supervision.

Children

Calcichew-D₃ Caplets are not intended for use in children.

Other medicines and Calcichew-D₃ Caplets

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. Calcium carbonate may interfere with the absorption of tetracyclines (a type of antibiotics) if taken at the same time. For this reason, tetracycline preparations should be taken at least 2 hours before or 4-6 hours after intake of Calcichew-D₃ Caplets.

Medicines containing bisphosphonates (used to treat osteoporosis) should be taken at least one hour before

intake of Calcichew-D3 Caplets.

Calcium can reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after Calcichew-D₃ Caplets.

The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Calcichew-D₃ Caplets.

Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Calcichew-D₃ Caplets.

Other medicines that may influence or be influenced by Calcichew-D₃ Caplets are: thiazide diuretics (used in treatment of high blood pressure and oedema) and cardiac glycosides (used to treat heart disorders).

Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, e.g. vitamin D₃.

If you are taking any of the above-mentioned medicines, your doctor will give you further instructions.

Calcichew-D3 Caplets with food and drink

Calcichew-D₃ Caplets can be taken with or without food and drink.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine. Pregnancy

Calcichew-D3 Caplets can be used during pregnancy, in case of calcium and vitamin D deficiency. During pregnancy you should not take more than 2500 mg calcium and 4000 IU vitamin D per day, as overdoses may harm the unborn child.

Breast-feeding

Calcichew-D3 Caplets can be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the child.

Driving and using machines

Calcichew-D₃ Caplets has no known influence on your ability to drive or use machines.

Calcichew-D₃ Caplets contains sorbitol and sucrose Calcichew-D3 Caplets contains sorbitol and sucrose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.

3. How to take Calcichew-D₃ Caplets

Always take this medicine exactly as your doctor has

told you. Check with your doctor or pharmacist if you are not sure.

Dosage:

The recommended dose is one tablet twice daily. The tablet may be swallowed or chewed.

Use in children

Calcichew-D3 Caplets are not intended for use in children.

If you take more Calcichew-D₃ Caplets than you should

If you may have taken more Calcichew-D₃ Caplets than you should, talk to your doctor or pharmacist immediately.

If you forget to take Calcichew-D₃ Caplets

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this

medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Hypersensitivity reactions have occurred with unknown frequency (cannot be estimated from the available data). If you experience the following symptoms, you should immediately contact a doctor. Swelling of the face, tongue, lips (angioedema) or swelling of the throat (laryngeal oedema).

Uncommon side effects (may affect up to 1 in 100 people): Excessive amounts of calcium in the blood (hypercalcaemia) or in the urine (hypercalciuria) may occur with large doses.

Calcichew-D₃

500 mg/400 IU Caplets

calcium/colecalciferol (vitamin D3)

100 film-coated tablets

For oral use: 1 tablet contains:

500 mg calcium (as calcium carbonate) 400 IU vitamin D₃ (10 microgram cholecalciferol) Sorbitol (E420) and sucrose.

Read the package leaflet before use. The tablet may be swallowed or chewed.

Keep out of the sight    [pi

and reach of children.

Do not store above 25°C. Keep the container tightly closed in order to protect from moisture.

Takeda UK Ltd.

Wooburn Green, BUCKS,

HP10 0DF, UK

PL 16189/0027

GBR F.7/xxxx/ 6083720 Code xxx

6083720_F7_V02_0516.indd 1

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